0001599298FALSE00015992982022-12-052022-12-05
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of
1934
Date of Report (Date of Earliest Event Reported):
December 5, 2022
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Summit Therapeutics Inc. |
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(Exact Name of Registrant as Specified in Its Charter) |
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Delaware |
001-36866 |
37-1979717 |
(State or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
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2882 Sand Hill Road, Suite 106, Menlo Park, CA
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94025 |
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(Address of Principal Executive Offices) |
(Zip Code) |
Registrant’s Telephone Number, Including Area Code:
617-514-7149
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Not applicable |
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(Former Name or Former Address, If Changed Since Last
Report) |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see
General Instruction A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the
Act:
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Title of Each Class |
Trading Symbol(s) |
Name of Each Exchange on Which Registered |
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Common stock, $0.01 par value per share |
SMMT |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
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Item 1.01 |
Entry into a Material Definitive Agreement.
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License Agreement
On December 5, 2022, Summit Therapeutics Inc. (the “Company” or
“Summit”) entered into a Collaboration and License Agreement (the
“License Agreement”) with Akeso, Inc. and its affiliates (“Akeso”)
and certain ancillary transaction documents as set forth in the
License Agreement. Pursuant to the License Agreement, the Company
is partnering with Akeso to in-license its breakthrough bispecific
antibody, ivonescimab. Ivonescimab, known as AK112 in China and
Australia, and also as SMT112 in the United States, Canada, Europe,
and Japan, is a novel, potential first-in-class bispecific antibody
combining the power of immunotherapy via a blockade of PD-1 with
the anti-angiogenesis benefits of an anti-VEGF into a single
molecule. Ivonescimab was engineered to bring two well established
oncology targeted mechanisms together. In connection with the
License Agreement, the Company has also entered into a Supply
Agreement with Akeso, pursuant to which Summit agree to purchase a
certain portion of drug substance for clinical and commercial
supply (the “Supply Agreement”).
The definitive partnership memorialized in the License Agreement
calls for Summit to receive the rights to develop and commercialize
ivonescimab (SMT112) in the United States, Canada, Europe, and
Japan (the “Licensed Territory”). Akeso will retain development and
commercialization rights for the rest of the regions including
China. In exchange for these rights, Summit will make an upfront
payment of $500 million, $300 million of which is payable within
the later of 15 days or upon the earliest date on which the parties
have actual knowledge that all applicable waiting periods under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR
Act”) and any comparable extension periods with respect to the
transactions contemplated by the License Agreement have expired or
been terminated (the “Antitrust Clearance Date”) (of which 16
million shares of Company common stock may be issued in lieu of
cash) and $200 million of which is payable within 90 days. The
total value of the upfront payment and potential milestone payments
is $5.0 billion, as Akeso will be eligible to receive regulatory
and commercial milestones of up to $4.5 billion. In addition, Akeso
will be eligible to receive low double-digit royalties on net
sales.
Ivonescimab is currently in clinical development and, pursuant to
the terms of the License Agreement, Summit will design and conduct
the clinical trial activities to support regulatory filings in the
Licensed Territory that Summit will submit. Pursuant to the terms
of the License Agreement, Summit will have final decision making
authority with respect to commercial strategy, pricing and
reimbursement and other commercialization matters in the Licensed
Territory. In connection with the License Agreement, Summit is
entering into a Supply Agreement as described above. Summit is not
assuming any liabilities (including contingent liabilities),
acquiring any physical assets or trade names, or hiring or
acquiring any employees from Akeso in connection with the License
Agreement. Akeso has incurred research and development expenses
relating to Ivonescimab, including pre-clinical studies, as well as
safety and efficacy clinical trials in non-licensed
territories.
In conjunction with the execution of the deal, Dr. Michelle Xia has
been appointed to the board of directors of Summit (the “Board”),
effective upon the Antitrust Clearance Date. The License Agreement
is subject to customary closing practices, including applicable
waiting periods under the HSR Act.
Note Purchase Agreement
On December 6, 2022, the Company entered into a Note Purchase
Agreement (the “Note Purchase Agreement”) and promissory notes with
the Company’s Chief Executive Officer, Chairman of the Board, and
beneficial owner of approximately 81% of the Company’s common
stock, Robert W. Duggan and Dr. Maky Zanganeh, the Company’s
co-Chief Executive Officer, President, member of the Board and
beneficial owner of approximately 6.4% of the Company’s common
stock. Pursuant to the Note Purchase Agreement, the Company agreed
to sell to each of Mr. Duggan and Dr. Zanganeh unsecured promissory
notes in the amount of $520 million.
Pursuant to the Note Purchase Agreement, the Company has issued to
Mr. Duggan and Dr. Zanganeh unsecured promissory notes in the
amount of $400 million and $20 million, respectively (the “February
Notes”), which will mature and become due on February 15, 2023 (the
“February Maturity Date”) and an unsecured promissory note to Mr.
Duggan in the amount of $100 million (the “September Note” and
together with the February Notes, the “Notes”), which will mature
and become due on September 15, 2023 (the “September Maturity Date”
and together with the February Maturity Date, the “Maturity
Dates”). The Maturity Dates may be extended one or more times at
the Company’s election, but in no event to a date later than
September 6, 2024. The Notes accrue interest at an initial rate of
7.5%. All interest on the Notes shall be paid on the date of
signing for the period through the February Maturity Date. Such
prepaid interest shall be paid in a number of shares of the
Company’s common stock, par value $0.01 (“Common Stock”) equal to
the dollar amount of such prepaid interest, divided by $0.7913 (the
consolidated closing bid price immediately preceding the time the
Company entered into the Note Purchase Agreement, plus $.01), which
shall be 9,720,291 shares. If the Company exercises its right to
extend the term of the February Notes, for all periods following
the February Maturity Date and, with respect to the September Note
following the February Maturity Date, interest shall accrue on the
outstanding balance of such extended Notes at the US prime interest
rate plus 50 basis points, as adjusted monthly, for three months
immediately following the Maturity Date, and thereafter at the US
prime rate plus 300 basis points, as adjusted monthly. In addition,
if the Company shall consummate a public offering, then upon the
later to occur of (i) five business days after the Company receives
the net cash proceeds therefrom or (ii) May 15, 2023, the February
Notes shall be prepaid by an amount equal to the lesser of (a) 100%
of the amount of the net proceeds of such offering and (b) the
outstanding principal amount on such Notes.
The Company may prepay any portion of the Notes at its option
without penalty. It is anticipated that the February Notes will be
repaid in connection with the consummation of the anticipated
rights offering announced by the Company, as described in Item 8.01
herein. The Notes were issued to Mr. Duggan and Dr. Zanganeh, as
applicable, in a private placement in reliance on Regulation D
promulgated under the Securities Act of 1933, as amended. The Notes
have not been registered under the Securities and Exchange Act of
1933, as amended, and may not be offered or sold absent
registration or an applicable exemption from registration
requirements.
The Company expects to use the proceeds of the Note Purchase
Agreement to support (i) payment of the upfront obligation
associated with the License Agreement as described in Item 1.01
herein, (ii) activities to support clinical development and
regulatory approval for SMT112; (iii) pursue business development
opportunities to expand our pipeline of drug candidates; and (iv)
general corporate purposes.
The foregoing summary of the Note Purchase Agreement and Notes do
not purport to be complete and is qualified in its entirety by
reference to the full text of the Note Purchase Agreement and Notes
filed as exhibits thereto, copies of which are attached hereto as
Exhibit 10.1 and are incorporated by reference herein.
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Item 2.01 |
Completion of Acquisition or Disposition of Assets.
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The applicable information set forth in Item 1.01 of this 8-K is
incorporated by reference in this Item 2.01.
Financial statements are not included in this 8-K because Summit
has determined, in accordance with the guidance set forth in
Regulation S-X Rule 11-01(d), that the License Agreement does not
involve the acquisition of a business.
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Item 5.02 |
Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers.
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Pursuant to the License Agreement described in Item 1.01 herein and
in conjunction with the execution of the deal, the Board
unanimously approved the election of Dr. Yu (Michelle) Xia as a
director of the Company, effective upon the Antitrust Clearance
Date.
Dr. Xia is the Co-Founder, Chairwoman, Chief Executive Officer of
Akeso which is party to the License Agreement discussed in Item
1.01 of this 8-K. In addition, she is a large individual
shareholder in Akeso.
On December 6, 2022, the Company issued a press release announcing
the approval by the Board of a rights offering to its stockholders.
The rights offering will be made through the distribution of
non-transferable subscription rights to purchase shares of Common
Stock as of the close of the market on the record date to be
determined by the Board, but which will be no earlier than January
23, 2023, at a price per share equal to the lesser of (i) $1.05, or
(ii) the volume weighted-average price of the Common Stock for the
five consecutive trading days through and including the expiration
date of the offering. Assuming that the rights offering is fully
subscribed, the Company expects to receive gross proceeds of up to
$500 million, less expenses related to the rights offering. The
Company intends to register the rights offering with the Securities
and Exchange Commission (the “SEC”) by filing a prospectus on Form
S-1. When available, a copy of the prospectus supplement may be
obtained at the website maintained by the SEC at
www.sec.gov.
The rights offering will include an over-subscription right to
permit each rights holder that exercises its basic subscription
rights in full to purchase additional shares of Common Stock that
remain unsubscribed at the expiration of the offering. The
availability of the over-subscription right will be subject to
certain terms and conditions to be set forth in the offering
documents. Robert W. Duggan, the Company’s Chairman of the Board
and Chief Executive Officer, and the beneficial owner of
approximately 81% of the Company’s issued and outstanding Common
Stock prior to this rights offering, and Dr. Maky Zanganeh, the
Company’s co-Chief Executive Officer, President, a member of the
Board, and the beneficial owner of approximately 6.4% of the
Company’s issued and outstanding Common Stock prior to this rights
offering, have each indicated that they intend to participate in
the Rights Offering and subscribe for at least the full amount of
their basic subscription rights, but have not made any formal
binding commitment to participate.
A copy of the press release related to the matters set forth herein
is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
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Item 9.01 |
Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit Number
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Description |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL
document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, hereunto duly
authorized.
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SUMMIT THERAPEUTICS INC. |
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Date: December 6, 2022 |
By: |
/s/ Ankur Dhingra |
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Chief Financial Officer |
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(Principal Financial Officer) |
Summit Therapeutics (NASDAQ:SMMT)
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